A Timely PDUFA V Benefits Patients and the Biopharmaceutical Industry

We've long said that the reauthorization of a clean PDUFA is the best way to make improvements to the FDA's drug review process that will encourage biopharmaceutical innovation and provide patients with more timely access to safe and effective new medicines. That said, we were surprised to see this article by Avik Roy on Forbes' blog The Apothecary. Roy asserts that the pharmaceutical industry wants only "window-dressing reforms" to the FDA regulatory process, and, for that reason, is opposing the TREAT Act introduced this week by Senator Kay Hagan (D-NC). This couldn't be further from the truth. In fact, our understanding is that Senator Hagan went the extra mile by working with BIO, FDA, PhRMA, and patient groups to reach a consensus agreement. We continue to believe in the benefits of a clean PDUFA; we believe the law should be reauthorized in a timely way, unencumbered by extraneous or controversial provisions. We applaud Senator Hagan for her consensus approach to supporting biopharmaceutical innovation.

That said, lawmakers need to be vigilant that adding multiple new requirements on the FDA and not jeopardize the agency's ability to accelerate review times and thereby delay patients' access to breakthrough new medicines. We've already seen how extraneous additions to past versions of PDUFA have slowed down the FDA's review of new medicines, ultimately causing a delay in the delivery of those innovative treatments to patients. Both FDA Commissioner Dr. Margaret Hamburg and Dr. Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research, have stated that the additional legislative burdens attached to the 2007 reauthorization of PDUFA dramatically slowed down FDA approvals for the next two years--ultimately hurting the very patients that PDUFA was enacted to protect.

That's why we're urging Congress to pass a PDUFA that stays faithful to the technical letter agreed upon by patient and consumer groups, industry representatives, and the FDA. Over the last year, we've seen real consensus that this agreement will improve the drug review process and help the FDA safely and efficiently review new medicines that help millions of people live longer, healthier lives. The agreement also has the support of many members of Congress, as we saw at the recent Energy and Commerce hearing on PDUFA reauthorization. Senators Mike Enzi (R-WY) and Tom Harkin (D-IA), leaders of the Senate Health, Education, Labor, and Pension Committee, applauded the FDA and industries for finalizing the agreements, and noted that "the user fee agreements are crucial to ensuring that medications become available to the American public quickly and safely."

The PDUFA V agreement actually takes great strides to streamline the FDA's regulatory process, making it more transparent, predictable, and scientifically-based. It calls for increased communication between drugmakers and FDA officials, additional flexibility in the review process, modernization of the regulatory framework, and incorporation of innovative tools such as biomarkers and pharmacogenics in the consideration of a new drug--all changes that benefit patients and the biopharmaceutical companies Roy discusses.

PDUFA V will enable the FDA to return to its focus: reviewing the safety, effectiveness, and the benefits and risks of innovative new medicines, and speeding those new cures and treatments to the patients who need them. Congress should act in a responsible and timely manner, and pass a PDUFA V without unnecessary legislative additions.